Pathogenic microorganisms may be present in human blood, body fluids or other infected materials and can cause infection and disease in persons who are percutaneously, or mucocutaneously, exposed. These pathogens include, but are not limited to, hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV). In this context, contaminated blood, body fluids or other infected materials may mean the presence or reasonably anticipated presence of pathogenic microorganisms on the surface or in a device.
A medical sharp is an object that can penetrate the skin and includes devices such as, but not limited to, needles, scalpels, tubes, wires, and other medical procedure objects, devices or instruments. Accidental puncture with contaminated, sharp needles or surgical instruments, referred to as medical sharps or sharps, remains a significant risk to healthcare workers. All healthcare workers, such as physicians, nurses, paramedics, emergency medical technicians, ambulance staff, airmedics, airmedic staff technicians, janitorial staff, office staff, and even patients and their families, are potentially at risk from this dangerous situation.
Typically, injuries resultant from accidental needle and scalpel sticks occur after the instruments have been used. As a result, healthcare workers are subject to serious diseases, including but not limited to hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
Most often, needle and scalpel punctures occur during the handling of used sharp instrumentation prior to permanent disposal. Healthcare workers can accidentally stick themselves or others in the vicinity while carrying contaminated instruments to a centrally located disposal container for used sharps. Often, needles dangerously protrude from the designated container, often located on a peripheral wall of a given room and often located behind furniture, fixtures, and medical equipment. This increases the risk of puncture to the healthcare worker placing the sharp in the container, or emptying the used sharps container.
The true cost of the problem is difficult to measure. For every “needlestick” exposure, the health care worker is subjected to batteries of tests that are repeated 3 to 4 times over the following year. If the risk is determined to be substantial, in terms of exposure to known or likely HIV, Hepatitis, or other pathogens, there may also be medication costs involved. There are side effects to medications administered for suspected disease transmission and the costs, both societal and monetary, are significant for such treatments. If a disease is actually transmitted by the event, the costs, both personal and financial, are staggering, and the event can prove to be career ending as well as adversely affecting the family and social life of the healthcare worker. Disease transmission, in the worst scenario, can be life ending for the exposed healthcare worker. Bearers of these costs, both tangible and intangible, include health care organizations, their insurers, governmental agencies, the health care workers and their families, and society as a whole.
Current solutions in the prior art include needle guards and covers, retractable needles, scalpel protectors and needleless connecting systems for intravenous solutions.
Although needle guards and covers, needles and needleless systems address part of the solution to the problem, they do not offer a universal solution that will manage the risks posed by other types of medical sharps, including scalpel blades, trocars, and the like.
The prior art includes protective devices for sharps. These are intended to enclose and blunt the used sharp, which prevents anyone from coming into contact with the contaminated sharp.
Current portable sharps containment devices accommodate needles, but may not accommodate thick sharps, such as cannulae, trocars, scalpels, hypodermic needles with an attached syringe barrel, and the like. It is generally against hospital policy and good medical practice to attempt to remove a sharp from its handle or syringe barrel because of the risk of needlestick or skin puncture and resultant contamination. Typically, sharps containment devices comprise a soft enveloping material having inadequate puncture resistance. In addition, current sharps containment devices may leak contaminated bodily fluids from the used sharp. Medical care facilities typically locate the sharps receptacle at a peripheral location within an area or room, and not at the point-of-use. There may be significant obstacles between the user and the sharps receptacle, including patient gurneys, beds, or examining tables; persons, such as patients, family members, visitors, and other health care workers; medical equipment such as IV poles and lines, monitors, wires, tubes, and other devices; or other furniture, fixtures, and equipment. This again creates the problem of the healthcare worker sticking a co-worker while moving the contaminated sharp to the disposal receptacle.
A typical sharps collector and disposal device is a mailbox-style container with or without a pull-down opening allowing access to the container. The user pulls the lid open, deposits the used sharp, and releases lid, which swings shut, much like mailing a letter. Mailbox-style containers without the pull-down opening have a tortuous path that the sharp must traverse to enter the container. The mailbox-style containers can be found in a variety of sizes and uses, such as in-hospital room containers, multi-purpose containers, mail-away containers, large volume and pharmacy containers, specialized containers, transportable containers, and the like.
A typical problem with mailbox-style receptacles is that they are frequently overfilled with needles, such that the needles stick out of the container opening. In addition, it may be difficult to put certain types of sharps, such as butterfly needles, needles attached to syringes, suture needles, trocars, cannulae, and the like, into them. An overfilled mailbox-style receptacle may result in healthcare workers becoming cut and infected by an already disposed-of sharp when they try to insert a new sharp into the receptacle and force their hand on the protruding sharp object, or by the new sharp itself. An additional risk of the mailbox-style receptacle includes the user being stuck as the sharp is being placed into the unit due to the difficulty of inserting the sharp into the tortuous pathway opening.
Not only are health care workers themselves at risk because of inadequate or unsafe disposal systems, but there are significant risks to housekeeping personnel within healthcare institutions and even to the public, who may encounter an improperly disposed, contaminated, unprotected, medical sharp device. Areas at risk include in-patient hospitals, outpatient facilities, emergency or ambulatory facilities, patient homes, offices, public restrooms, physician's offices, nursing homes, laboratories, emergency medical facilities, military facilities, helicopters, airplanes, airmedic facilities, employer facilities, hospice care facilities, needle dispensing facilities for heroin addicts and diabetics, and the like. Unprotected contaminated medical sharps are occasionally found in public areas such as public beaches, parks, and children's play areas.
New devices, procedures, systems, and methods are needed for guarding, dispensing, and collecting contaminated sharps to minimize the risk of accidental wounding of healthcare workers and others by infectious, sharp devices. Such devices and procedures are particularly important in any medical setting including in-hospital, pre-hospital, outpatient, military, and the emergency department.